Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a pilot study
This research study is exploring if a specific medication, psilocybin (sometimes called magic mushrooms), combined with talking therapy, might be a helpful new way to treat gambling disorder. It's a 'pilot' study, which means it's an early look into the treatment to see if it's safe and if people can complete the full course. Researchers want to understand if this approach could reduce gambling behaviours and improve a person's well-being. Different doses of psilocybin are being tested, including a very small amount and a placebo (a dummy pill) to compare the effects. The study will also track how people feel, their general mood, and how well they cope during and after the treatment.
At a glance
What is this study about?
This study is investigating a new and potentially helpful way to treat gambling disorder. Gambling disorder can have a significant impact on a person's life and relationships, and researchers are always looking for more effective treatments. This particular study is exploring the use of a medicine called psilocybin, which will be given alongside talking therapy. You might be familiar with psilocybin as the active ingredient in 'magic mushrooms'. However, in this study, it's being used in a controlled and medical setting.
The main goal of this study is to see if people can complete the full treatment plan – including all the therapy sessions and follow-up appointments – and if the treatment is generally well-tolerated. It's a 'Phase II' study, which means it's an early stage to learn more about the treatment's safety and how it works, rather than a final large-scale trial. The study will involve different doses of psilocybin, and some people will receive a placebo (a pill with no active medicine) to help researchers understand the true effects of the psilocybin.
Researchers will be carefully checking many things, like changes in how strong gambling urges are, how often people gamble, and their overall mood. They will also look at feelings of self-compassion, spirituality, and how confident people feel about managing their gambling. This information will help them decide if similar studies should be done in the future with more participants.
Key takeaways
- This study is looking at psilocybin and therapy to treat gambling disorder.
- It's an early-stage study to check safety and how well people complete the treatment.
- Participants will receive either psilocybin (different doses) or a dummy pill (placebo).
- Talking therapy sessions are a key part of the treatment plan.
- Your well-being, mood, and gambling habits will be closely monitored.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
Since this study is specifically looking at gambling disorder, you would need to have been diagnosed with this condition to be considered. There will also be other specific health checks and questionnaires to make sure the study is a good fit for you and that taking part would be safe.
It's important to remember that not everyone who has gambling disorder will be able to join. The research team will review everyone's medical history and current health to ensure they can take part safely.
- Am I 18 years old or older?
- Have I been diagnosed with gambling disorder?
- Am I open to receiving talking therapy?
- Am I prepared to attend all scheduled study appointments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would first go through a screening process to make sure you meet all the health requirements. If you're eligible, you would be randomly assigned to one of several groups. Some groups will get different doses of psilocybin capsules (1mg, 5mg, or 25mg), while another group will receive a placebo capsule (a dummy pill with no active medicine).
The study involves completing all scheduled visits and procedures. This includes attending sessions where the study medicine is given, combined with talking therapy sessions (PAP sessions). You'll also have follow-up assessments afterwards to see how you're doing. These assessments will involve answering questions about your gambling, your mood, and your overall well-being. Throughout the study, your heart rate and blood pressure will be checked. Researchers will also keep an eye on any side effects you might experience. The full duration of your participation, including all sessions and follow-up checks, will be explained in detail by the study team.
Potential risks and benefits
Locations (1)
- —France
Common questions
What is psilocybin?
Psilocybin is a natural substance, sometimes known as the active ingredient in 'magic mushrooms'. In this study, it's being used as a specially prepared medication under strict medical supervision.
What is a 'pilot study'?
A pilot study is an early research step to test if a treatment is safe, well-tolerated, and if people can complete the study plan. It helps researchers decide if bigger studies should be done.
Will I know if I'm getting psilocybin or a placebo?
No, this study is 'blinded', meaning neither you nor the study team will know if you're receiving the psilocybin or the placebo until the study is over. This is to ensure fair results.
What kind of therapy will be involved?
The study involves 'psilocybin-assisted psychotherapy', which means talking therapy sessions will be provided alongside the psilocybin medication to help you work through your gambling disorder.
What happens if I want to stop participating?
You are free to leave the study at any point, for any reason, without it affecting your usual medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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